EverImmune raises €5M to enter clinical phase in microbiome immuno-oncology

Villejuif, near Paris, France, November 30, 2021 – EverImmune, a biotechnology company specialized in the development of live biotherapeutic products in the field of microbiota oncology, today announces it has raised more than €5 million (approx. $6M) in a Series A funding from undisclosed private investors.

EverImmune was created in 2016 as a spinoff from Gustave Roussy; Europe’s first cancer institute, based near Paris, France. It harnesses the gut microbiota for the development of a unique theragnostic approach combining diagnostic and therapeutic technologies to restore the response to Immune Checkpoint Inhibitors (ICIs) in cancer patients.

The proceeds of this funding will support the clinical development of Oncobax® AK (Akkermansia), a Live Biotherapeutic Product (LBP) used as an oral adjuvant to anticancer immunotherapies. This technology is designed to safely boost the immune system and restore sensitivity to immunotherapies in primary resistance settings. The company intends to start its first Phase I clinical trial for Oncobax AK in Q2, 2022 – in Non-Small Cell Lung Cancer (NSCLC) and Renal Cell Cancer (RCC).

Used either in monotherapy or in association with cancer treatments, ICIs are anticancer immunotherapies that have revolutionized the clinical management of many tumor types with previously poor prognosis, including renal and advanced lung cancer. However, responses to ICIs are heterogeneous, with patients showing primary or secondary resistance to them, and can be transient. It is critical to identify the parameters that modulate the anticancer immunity needed to trigger the effectiveness of anticancer therapeutics.

Evidence accumulated over the past decade has highlighted the role of the gut microbiota¹ in the effectiveness of anticancer immunotherapies in preclinical tumor models, as well as in cancer patients. Everimmune’s founders were pioneers in the discovery of the prognostic role of microbiota composition for the clinical benefit of these patients treated with immunotherapy, as well as in the demonstration of the adjuvanting role of certain intestinal bacteria to boost antitumor immunity and to counteract primary resistance to treatment.

EverImmune identified Akkermansia (AK) as a commensal bacteria, modulating the effectiveness of anti-cancer immunotherapies in patients with lung or kidney cancer. The company was able to demonstrate this through its extensive preclinical research². The data was validated in animal models using tumor-bearing mice. Oncobax AK is an adjuvant for ICI-based immunotherapy that contains a specific strain of Akkermansia.

“We are delighted to receive this funding to support this project that pioneers the clinical use of therapeutic bacteria, to improve the efficacy of immunotherapy treatments,” said Jean-Luc Marsat, chairman of EverImmune. “Today, only 30% of NSCLC and 40% of RCC patients respond to immunotherapy treatments. Thanks to Oncobax AK, we aim to significantly increase the percentage of patients who will benefit from immunotherapy treatments. EverImmune is thrilled to welcome new investors; I would also like to thank them for trusting us during this first phase of our project.”

“This fundraising is genuine recognition of EverImmune’s unique pipeline and technology -designed to overcome resistance to immunotherapy treatment in cancer patients. As a leading cancer institute, our role at Gustave Roussy is to support breakthrough innovations in cancer treatment. EverImmune is one of the spinoffs that we supported from day one; we are excited to see the company entering this new phase in its development and preparing its clinical trial for Oncobax AK,” said Christophe Javaud, COO of Gustave Roussy Transfert.

Following the first preclinical results obtained in 2016, EverImmune plans to launch the Oncobax AK clinical trial, initially with 66 patients (33 NSCLC and 33 RCC), followed by a cohort extension of an extra 50, to evaluate its safety and efficacy. Oncobax AK – lyophilized, formulated in delayed release capsules – will be used as an oral adjuvant for cancer immunotherapy.

EverImmune also develops a broader pipeline of products comprising additional bacteria endowed with robust adjuvant potential in different types of cancer, such as breast and colon cancers.

Legal advisers: Winston & Strawn

Strategy and transaction advisers: AEC Partners

About EverImmune

EverImmune is a biotechnology company specialized in the development of live biotherapeutic products in the field of microbiota oncology. It harnesses the gut microbiota for the development of a unique theragnostic approach to restoring the response of Immune Checkpoint Inhibitors (ICIs) in cancer patients. The company is developing Oncobax® AK, a Live Biotherapeutic Product (LBP) used as an oral adjuvant to anticancer immunotherapies, designed to safely boost the immune system and restore sensitivity to immunotherapies in primary resistance settings. EverImmune plans to start its Phase I clinical trial for Oncobax AK in Q2, 2022, in Non-Small Cell Lung Cancer (NSCLC) and Renal Cell Cancer (RCC). It also develops other bacteria in its pipeline for use in the treatment of different types of cancer, such as breast and colon cancers.

Created in 2016 by co-founders Pr. Laurence Zitvogel and Dr. Romain Daillere, EverImmune is a spinoff from Gustave Roussy; Europe’s first cancer institute, based in Paris, France. The company is part of ONCOBIOME, the first European program dedicated to microbiome and cancer, funded by the European Union.

Based in Villejuif, near Paris, EverImmune has five staff.

www.everimmune.com

References:

• Routy et al., Gut microbiome influences efficacy of PD-1–based immunotherapy against epithelial tumors, 2018 Jan 5;359(6371):91-97. doi: 10.1126/science.aan3706 – https://www.science.org/doi/full/10.1126/science.aan3706
• Derosa et al., Eur Urol. 2020. Aug;78(2):195-206. doi: 10.1016/j.eururo.2020.04.044. – https://pubmed.ncbi.nlm.nih.gov/32376136/